Atlas FDA

OTP

31 FDA 510(k) clearances · Product code

69 daysmedian time to decision
164 days90th percentile
31clearances measured

FDA profile

Official device name
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device class
Class III (high risk)
Regulation
21 CFR 884.5980
Medical specialty
Obstetrics/Gynecology
Flags
Implant
FDA definition
Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally
Adverse events (MAUDE)
2020: 175 · 2021: 647 · 2022: 114 · 2023: 59 · 2024: 35 · 2025: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM (K122459)Boston Scientific Corporation2012-12-13
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION (K121612)American Medical Systems2012-07-20
AMS ELEVATE PC (K112842)American Medical Systems, Inc.2011-10-25
LITE PELVIC FLOOR REPAIR KITS (K103426)Boston Scientific Corp2011-09-14
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM (K112386)Coloplast Corp.2011-09-08
SURELIFT PROLAPSE SYSTEM (K102815)Neomedic International2011-07-07
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K111118)American Medical Systems2011-07-01
RESTORELLE POLYPROPYLENE MESH (K092207)Mpathy Medical Devices, Inc.2009-08-04
PELVIC FLOOR REPAIR SYSTEM (K091131)Boston Scientific2009-05-08
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (K083499)Coloplast A/S2009-05-08
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP (K090713)American Medical Systems, Inc.2009-04-02
ASCEND (K083722)Caldera Medical, Inc.2009-03-31
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM (K083839)C.R. Bard, Inc.2009-01-15
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K082677)American Medical Systems, Inc.2008-12-23
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM (K082387)American Medical Systems2008-12-04
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE (K082730)American Medical Systems, Inc.2008-11-26
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE (K081710)American Medical Systems2008-10-15
AVAULTA SUPPORT SYSTEM (K082571)C.R. Bard, Inc.2008-09-30
PINNACLE PELVIC FLOOR REPAIR KIT II (K081048)Boston Scientific Corp2008-08-22
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS (K071512)ETHICON, Inc.2008-05-15
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM (K080185)American Medical Systems, Inc.2008-04-10
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES (K072951)Sofradim Production2007-12-19
PINNACLE PELVIC FLOOR REPAIR KITS (K071957)Boston Scientific Corp2007-11-08
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM (K063712)C.R. Bard, Inc.2007-03-12
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS (K063562)ETHICON, Inc.2007-02-26
MENTOR NOVASILK MESH (K053414)Mentor Corp.2005-12-27
UGYTEX SUAL KNIT MESH (K051503)Sofradim Production2005-08-05
AMS PERIGEE SYSTEM (K040623)American Medical Systems, Inc.2004-05-17
AMS APOGEE VAULT SUSPENSION SYSTEM (K040537)American Medical Systems, Inc.2004-04-22
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH (K040521)American Medical Systems, Inc.2004-03-24
AMS LARGE PORE POLYPROPYLENE MESH (K033636)American Medical Systems, Inc.2003-12-31

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Every clearance here is in the API, with alerts when new ones post.